Universal sterilizing tool

ABSTRACT

The sterilizing tool is configured to wipe debris from and to sterilize and/or dry a working end-site of medical device; using a wiping, twisting, dabbing, push/pull, and/or screwing motion around all of the surface aspects of the device to be sterilized. Additionally, the sterilizing tool is configured to form fit to the surfaces of the end-site and to apply an inclusive layer of an anti-pathogenic agent to the inner and outer surfaces of the working end-site. The sterilizing tool may be frictionally engaged with and retained on the working end-site until removed and the end-site is ready for use. The sterilizing tool is intended for a one time, single use, disposable application.

BENEFIT CLAIM

This application is a continuation-in-part of U.S. application Ser. No.12/300,717, filed on Nov. 13, 2008, entitled “Universal SterilizingTool”, which is a 371 application of International Application No.PCT/US2008/076864, filed Sep. 18, 2008, entitled “Universal SterilizingTool”, which claims the benefit of U.S. Provisional Application No.61/050,769, filed on May 6, 2008, entitled “Universal ContouredSterilizing Tool”, the entireties of which are incorporated by referenceherein for all purposes.

TECHNICAL FIELD

The present invention relates to devices and methods for sterilizing themedical connection sites of luer connections, luer compatiblecomponents, catheter hubs, and other medical connections and accessports. More particularly, the present invention relates to a contouredsterilizing element that is configured to form-fit to the various shapesand working aspects of the component being sterilized.

BACKGROUND

Mating luer connections, needleless connectors, and needle access portsserve as a conduit for administering medication to a patient by thejoining of their mutual complimentary components. Prior to connectingtwo luer compatible components together, it is important to sterilizethe connection end-sites. Typically, the connection end-sites aresterilized by wiping each site with an antiseptic wipe. Contacting andcleaning intricate details on an end-site such as cracks, crevices orgrooves and where microscopic bacterium can reside on an end-site, andparticularly, where an end-site has been assembled with multiplecomponents having microscopic surfaces that can harbor bacterium (e.g.needle-less connector having assembled components such as a housing,seals, valve or septum) requires an awareness to effectively sterilizeand thoroughly kill those pathogens that would otherwise make an alreadysick patient worse. The wiping and sterilizing of the connectionend-sites must be done for a specified amount of time and accuracy toachieve a “kill of microbes” prior to the luer compatible componentsbeing connected together to reduce the risk of infection to the patient.This is also true for needle access ports or other connections. Withoutthis simple precautionary step of sterilizing the working end-sites,patients are at a greater risk of contracting an infection.

The current method for sterilizing a connection end-site, catheter hub,needle access port, or needleless connector employs an antiseptictowelette that comes in a small foil packet and is commonly usedthroughout hospitals, clinics, and home healthcare. The foil packet inwhich the antiseptic towelette comes in must be torn open and thetowelette lifted out with gloved hands. The towelette is a small foldedsheet of fibrous, non-woven material that contains isopropyl alcohol.The clinician cannot adequately use the towelette to wipe the variouscomplex surfaces, edges, threads, lumen, septum of a working end-sitedue to the towelette's small size and flimsy characteristics. Thus, thatwhich should be a routine precautionary step to maintain sterility isunfortunately either ignored or not adequately performed to preventpatient infection.

SUMMARY

According to various embodiments, the present invention is a contoured,pre-moistened anti-pathogenic sterilizing element for wiping medicalluer compatible connector end-sites, needleless connector end-sites,and/or needle access port end-sites. According to some embodiments, thesterilizing element is pre-shaped to contour to the outer and innersurfaces of the working end-site of a medical device such that itcontacts the outer and inner surfaces of the working site. A wipingand/or a twisting motion is used to wipe debris from and apply a layerof an anti-pathogenic agent to the site. In some embodiments, thesterilizing element is contained in a flexible tubular or rectangularhousing.

According to other embodiments, the present invention is a universallyadaptable, contoured sterilizing element that is contained within asmall ergonomic housing configured to be held in the fingers of onehand. In some embodiments, the housing may be opened by using thefingers of one hand to squeeze the lateral sides, or by forcibly pushinga site end through a sealed membrane or frangible lid to engage thecontoured sterilizing element. In other embodiments, the cover can bephysically removed from the top of the housing to access the contouredsterilizing element contained within the housing. In other embodiments,the sterilizing element may be left engaged with the working end-siteuntil the end-site is ready for use.

According to some embodiments, the present invention is a sterilizingelement for cleaning and sterilizing outer and inner surfaces of aworking end-site of a medical device. The sterilizing element includesan anti-pathogenic agent. According to some embodiments, the sterilizingelement may be pre-moistened or impregnated with the anti-pathogenicagent. According to other embodiments, the anti-pathogenic agent may bebonded to a surface of the sterilizing element. The sterilizing elementincludes a first end and a second end and a recessed portion configuredto receive the working end-site of the medical device therein.Additionally, the recessed portion includes an inner surface configuredto contour to and contact the outer surfaces of the working end-site ofthe medical device and a raised base portion configured to contact andengage the inner surfaces of the working end-site of the medical device.

According to another embodiment, the sterilizing element includes firstand second ends and a recessed portion configured to inwardly receivethe working end-site of the medical device. In certain embodiments, therecessed portion includes: a base portion configured to contact a distalend of the working end-site; an inner surface configured to contour andform-fit to the outer surfaces of the working end-site of the medicaldevice; and an inner diameter that tapers down from the first end to thesecond end of the sterilizing element. According to some embodiments,the sterilizing element may be pre-moistened or impregnated with theanti-pathogenic agent. According to other embodiments, theanti-pathogenic agent may be bonded to a surface of the sterilizingelement.

In other embodiments, the present invention is a sterilizing device forwiping and sterilizing outer and inner surfaces of a working end-site ofa medical device including a housing and a sterilizing element securedand contained within the housing. In some embodiments, the housingincludes at least one end adapted to be opened, and sidewalls having anouter surface. In some embodiments, the sterilizing element includes afirst end, a second end, and a recessed portion configured to receiveand engage the outer surfaces of the working end-site. In certainembodiments, the recessed portion includes an inner surface configuredto contour to and contact the outer surfaces of the working end-site anda raised base portion configured to contact and engage the innersurfaces of the working end-site. According to some embodiments, thesterilizing element may be pre-moistened or impregnated with theanti-pathogenic agent. According to other embodiments, theanti-pathogenic agent may be bonded to a surface of the sterilizingelement.

In some embodiments, the at least one end adapted to be opened includesa seal adapted to be transitioned from a closed configuration to an openconfiguration by the application of an inward pressure applied to thesidewalls of the housing. In other embodiments, the at least one endadapted to be opened includes a lid adapted to be removed from thehousing by the application of an inward pressure applied to thesidewalls of the housing.

In certain embodiments, the housing includes an envelope of a flexiblematerial and wherein the at least one end comprises a removable portion.In further embodiments, the housing includes an envelope of a flexiblematerial having a lining, the lining comprising the sterilizing elementaccording to the various embodiments of the present invention.

In some embodiments, the at least one end adapted to be opened includesa frangible lid. According to various embodiments, the frangible lid canbe made of plastic, mylar, foil, laminated foil, laminate, or othersimilar material. In other embodiments, the at least one end adapted tobe opened includes a pre-scored lid. In still other embodiments, the atleast one end comprises a peel-away lid. According to furtherembodiments, the housing includes a protective cover secured adjacent tothe at least one end adapted to be opened.

In some embodiments, the housing further includes a removable coversecured over the at least one end adapted to be opened. According tosome embodiments, the removable cover includes a second sterilizingelement contained and secured within the removable cover. Thesterilizing element includes a first end and a second end and a recessedportion configured to receive and contact the outer surfaces of theworking end-site. The recessed portion includes an inner surfaceconfigured to contour to and contact the outer surfaces of the workingend-site and a raised base portion configured to contact and engage theinner surfaces of the working end-site. According to some embodiments,the sterilizing element may be pre-moistened or impregnated with theanti-pathogenic agent. According to other embodiments, theanti-pathogenic agent may be bonded to a surface of the sterilizingelement.

According to some embodiments, the present invention is a dual-endedsterilizing device including an elongated housing comprising a firstportion having a first end adapted to be opened and a second portionhaving a second end adapted to be opened, and a first sterilizingelement contained and secured within the housing. The sterilizingelement includes at least one end configured to inwardly receive aworking end-site of a medical device therein to conform to and contactat least the outer surfaces of the working end-site. According to someembodiments, the sterilizing element may be pre-moistened or impregnatedwith the anti-pathogenic agent. According to other embodiments, theanti-pathogenic agent may be bonded to a surface of the sterilizingelement.

According to some embodiments, the sterilizing element includes asingle, continuous foam piece extending from the first end of the firstportion of the housing to the second end of the second portion of thehousing. The continuous foam piece generally includes a first end and asecond end. Each end of the continuous foam piece is configured toinwardly receive the working end-site therein, and to contour to atleast the outer surfaces of the working end-site of the medical device.According to some embodiments, the sterilizing element may bepre-moistened or impregnated with the anti-pathogenic agent. Accordingto other embodiments, the anti-pathogenic agent may be bonded to asurface of the sterilizing element.

According to some embodiments, the dual ended sterilizing device furtherincludes a partition separating the first portion of the housing fromthe second portion of the housing. The first sterilizing element issecured within the first portion of the housing. In some embodiments,the dual ended sterilizing device includes a second sterilizing elementcontained and secured within the second portion of the housing.According to various embodiments, the second sterilizing elementincludes an anti-pathogenic agent and at least one end configured toinwardly receive and conform to at least the outer surfaces of theworking end-site. In other embodiments, a sterile drying element can becontained and secured within the second portion of the housing. Thesterile drying element can be configured to inwardly receive and conformto at least the outer surfaces of the working end-site. In certainembodiments, the drying element may be left engaged with the workingend-site until the site is ready for use. In still other embodiments,the dual ended sterilizing device includes a female luer connectorsecured to the partition and contained within the second portion of thehousing. The female luer connector can be adapted to connect to any oneof a male luer lock, slip luer, or thread luer connector.

According to some embodiments, the present invention provides a methodof wiping, drying, and sterilizing a medical device including a workingend-site having inner and outer surfaces including: providing asterilizing element comprising an anti-pathogenic agent, and a recessedportion having an inner surface configured to contour to the outersurfaces of the working end-site and a raised portion configured tocontact and engage the inner surfaces of the working end-site; insertingthe working end-site into the recessed portion of the sterilizingelement to engage the working end-site therein; wiping and sterilizingthe working end-site located within the recessed portion, removing theworking end-site from the sterilizing element, and air-drying theworking end-site for a period of time. In some embodiments, the methodfurther includes disposing of the sterilizing element after the initialuse.

In some embodiments, the method further includes forcibly engaging theworking end-site through the at least one end adapted to be opened toaccess the sterilizing element contained within the housing. In otherembodiments, the method further includes squeezing the sidewalls of thehousing to transition the at least one end from a closed configurationto an open configuration to access the sterilizing element containedwithin the housing. In certain embodiments, the at least one end of thehousing may be transitioned from a closed configuration to an openconfiguration using the fingers on a single hand.

In some embodiments, the method further includes compressing thesterilizing element to expel the anti-pathogenic agent from thesterilizing element and onto the working end-site. In some, the step ofcompressing the sterilizing element includes engaging the workingend-site in the recessed portion of the sterilizing element. In otherembodiments, the step of compressing the sterilizing element includessqueezing the sidewalls of the housing to expel the anti-pathogenicagent from the sterilizing element onto the working end-site.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a contoured sterilizing element providedin accordance with an embodiment of the present invention.

FIG. 2A-2C are cross-sectional views of a contoured sterilizing elementin accordance with various embodiments of the present invention.

FIG. 3 is an isometric view of a sterilizing element according toanother embodiment of the present invention.

FIG. 4 is a cross-sectional view of a contoured sterilizing elementengaged with a thread luer connector.

FIGS. 5A and 5B are isometric views of a sterilizing device according toone embodiment of the present invention.

FIG. 6 is an isometric view of a sterilizing device according to anotherembodiment of the present invention.

FIG. 7A is an isometric view of a sterilizing device including a housinghaving a removable cover according to still another embodiment of thepresent invention.

FIG. 7B is an isometric view of the sterilizing device shown in FIG. 7A,wherein the housing cover is removed.

FIG. 8 is an isometric view of a sterilizing device including a housinghaving a removable lid provided in accordance with an embodiment of thepresent invention.

FIG. 9 is an isometric view of the sterilizing device shown in FIG. 8,wherein the lid is removed.

FIG. 10 is an isometric view of a sterilizing device including a housinghaving a tear off end provided in accordance with an embodiment of thepresent invention.

FIG. 11 is an isometric view of the sterilizing device shown in FIG. 10,wherein the end is removed.

FIG. 12 is an isometric view of a sterilizing device according to yetanother embodiment of the present invention.

FIG. 13A is an isometric view of a sterilizing device including afrangible top according to an embodiment of the present invention.

FIG. 13B is an isometric view of a working end-site forcibly engagedthrough the frangible top of a sterilizing device.

FIG. 14 is an isometric view of a sterilizing device including aprotective cover according to other embodiments of the presentinvention.

FIG. 15 is an isometric view of a dual sided sterilizing deviceaccording to another embodiment of the present invention.

FIG. 16 is an isometric view of a dual sided sterilizing deviceaccording to yet another embodiment of the present invention.

FIGS. 17 and 18 are isometric views of a combined sterilizing deviceaccording to yet another embodiment of the present invention.

FIGS. 19A and B are partial cut-away views of a sterilizing deviceconfigured to be attachable to a syringe according to yet otherembodiments of the present invention.

FIG. 20 is a perspective view of a sterilizing device including asterilizing element provided in accordance with various embodiments ofthe present invention, in use.

FIG. 21A is a partial cut-away view of a sterilizing device provided inaccordance with various embodiments of the present invention and a maleluer lock connector end.

FIG. 21B is a partial cut-away view of the sterilizing device shown inFIG. 21A used to clean the male luer lock connector end.

FIGS. 22A and 22B are isometric views of a contoured sterilizing toolaccording to still another embodiment of the present invention.

FIG. 23 is an isometric view of a contoured sterilizing tool accordingto yet another embodiment of the present invention.

FIG. 24 is a schematic view of a contoured sterilizing tool provided inaccordance with an embodiment of the present invention contained withina packaging.

DETAILED DESCRIPTION

All medical luers and all medical device ends need to be sterilizedprior to use. The term “luer” is well known in the medical field and inthe art and is used here (luer hub, male luer, female luer, slip luer)to mean mating structures, with or without threads, that allows twomating luer devices, or luer compatible components, to be joined forfluid communication. The term “site,” “end-site” or “site end” is usedinterchangeably and is used here to be understood to mean any and allworking ends and/or sites including, but not limited to, a luer, luerhub (e.g. catheter hub), luer compatible component, needle access port,needleless connector, or septum. According to various embodiments, thepresent invention is a tool for effectively sterilizing and wipingdebris from all surfaces of a working end including, but not limited to,threads, sides, edges, inner lumens, septums, and needle access ports.

FIG. 1 is an isometric view of a contoured sterilizing element 20provided in accordance with various embodiments of the presentinvention. FIGS. 2A-2C are cross-sectional views of the contouredsterilizing element 20, as shown in FIG. 1, according to variousembodiments of the present invention. The sterilizing element 20 isconfigured to wipe debris from and to sterilize and/or dry a workingend-site of a catheter hub, luer connector, luer component, and/oraccess port using a wiping, twisting, dabbing, push/pull and/or screwingmotion around all of the surface aspects of the device to be sterilized.Additionally, the sterilizing element 20 is configured to apply aninclusive layer of an anti-pathogenic agent to the inner and outersurfaces of the working end-site. An inclusive layer, as used herein, isa layer of the anti-pathogenic agent applied via the contoured aspectsof the sterilizing element which contacts all accessible inner and outersurfaces of the working end-site and contains an amount of thepathogenic agent sufficient to effectively sterilize the workingend-site of the medical device. The contoured sterilizing element 20 isintended for a one time, single use, disposable application.

The sterilizing element 20 can be made from a variety of materialsincluding, but not limited to, non-woven, particulate-free absorbentfoams, natural or synthetic sponges, or other suitable materials, bothsemi-flexible or semi-ridged, known to those of skill in the art. Insome embodiments, the contoured sterilizing element 20 includes anabsorbent foam article 22. In other embodiments, the contouredsterilizing element 20 is formed from an absorbent, viscoelasticresilient foam or silicone rubber.

According to some embodiments, the absorbent material can be pre-shapedor pre-molded such that it is configured to contour to the surfaces ofthe working end to be sterilized. For example, in some embodiments, thesterilizing element 20 can be contoured and pre-shaped such that it isconfigured to form-fit over the working end-site of a medical connector,catheter hub, luer compatible connector, luer component, and/or needleaccess port for efficient wiping and sterilizing. In other embodiments,the sterilizing element 20 can be shaped to contour to and engage aninner lumen, septum, port, and/or needleless injection site. In otherembodiments, a micropatterned or microtextured surface on thesterilizing element 20 provides an additional refinement to the contoursterilizing tool for contacting and cleaning intricate details on anend-site such as cracks, crevices or grooves and where microscopicbacterium can reside on an end-site, and particularly, where an end-sitehas been assembled with multiple components having microscopic surfacesthat can harbor bacterium (e.g. needle-less connector having assembledcomponents such as a housing, seals, valve or septum). Themicrotexturing or micropatterning can include any one of a number ofridges, bumps, surface roughing, rings, concentric circles, latticefeatures and the like. In yet other embodiments, the sterilizing element20 is configured to engage a working end-site of a medical device suchthat a friction fit is created between the sterilizing element 20 andthe end-site of the medical device. The sterilizing element 20 canremain frictionally engaged with the working end-site until ready foruse. According to another embodiment, the absorbent foam material issufficiently resilient such that it conforms to the surfaces of theworking end-site when the working end-site is depressed into theabsorbent material.

According to various embodiments, the absorbent material includes ananti-pathogenic agent including any one of an antiseptic, disinfectant,microbiocidal, or combinations thereof to kill pathogens on the surfacesof the device. According to one embodiment, an anti-pathogenic agent isa dry agent bonded to the surfaces of the sterilizing element. Accordingto another embodiment, the sterilizing element is impregnated with ananti-pathogenic agent. For example, the sterilizing element may beimpregnated with an oligodynamic metal. An oligodynamic metal is a metalshown to have anti-bacterial properties even in minute quantities.Exemplary oligodynamic metals include, but are not limited to, thefollowing: gold, zinc, copper, and cerium. According to one embodiment,the sterilizing element may be impregnated with silver. In otherembodiments, the absorbent material is pre-moistened with at least oneanti-pathogenic agent. Exemplary anti-pathogenic agents include, but arenot limited to, the following: isopropyl alcohol, povidone iodine,chlorhexidine gluconate, and other useful anti-pathogenic agents knownto those of skill in the art. Additionally, depending on theanti-pathogenic agent used, a sufficient amount of anti-pathogenic agentcan be incorporated into microporous surface of the absorbent materialto achieve an acceptable ratio of “anti-pathogenic agent to dry-time,”wherein a sufficient amount of anti-pathogenic agent is impregnated intothe microporous surface and is used to adequately disinfect the site endwhile at the same time achieving a fast drying rate. The end-siteconnector devices should be sterile, dry, and free of anti-pathogenicresidue, or additionally provide an anti-pathogenic residue that wouldmaintain the sterility of the end-site until use by the clinician and benon-toxic and compatible to both the patient and the end-site materialsince the connector end-sites complete the pathway of medication intothe patient's body prior to their connection. According to oneembodiment, the drying rate after the anti-pathogenic agent has beenapplied to the working end-site is less than about 15 seconds. In otherembodiments, the drying rate is less than about 10 seconds. In stillother embodiments, the drying rate is less than about 7 seconds.

In some embodiments, the working end-site undergoes a visual change inappearance when contacted with the anti-pathogenic agent containedwithin the sterilizing element 20. For example, in some embodiments, thesterilizing element 20 releases the anti-pathogenic agent upon contactwith the working end-site of the medical device, wetting the surfacewith the anti-pathogenic agent and causing a visual change in theend-site due to a microtextured microporous (e.g., a polymeric porouspermeable polymer), micropatterned, bonded or solvatochromic dyedsurface (e.g., merocyanine dye or Reichardt's dye) of the end-site.Exemplary surfaces of a working end-sit adapted to undergo a visualchange upon contact with an anti-pathogenic agent or other changeinitiating reactant are generally shown and described in U.S. PublishedApplication No. 2008/0021381, entitled “Medical Fluid Access Device withAntiseptic Indicator,” the entirety of which is incorporated byreference herein for all purposes. As a result of contact with theanti-pathogenic agent, the working end-site can visually change from afirst state to a second state such as, for example, from visually lightto visually dark or from a dark surface to a light surface over time dueto exposure to the anti-pathogenic agent or from a wetted surface to adry surface.

In other embodiments, the sterilizing element 20 itself can be adaptedto undergo a visual change. For example, the sterilizing element 20 isimpregnated with an anti-pathogenic agent such as IPA (isopropylalcohol) and can visually change from a darker appearance when contactis first made with the working end-site to a lighter appearance as whenthe sterilizing element 20 is left in place on the working end-site andthe anti-pathogenic agent dries and/or evaporates. In some embodiments,the sterilizing element 20 can include a micropatterned (such finelines, cracks), microporous or microtextured surface, such as describedabove, that is adapted to undergo the visual change.

In yet another embodiment, the sterilizing element 20 is impregnatedwith a visual change reactant that when applied to working end-siteindicates that the end-site has been contacted with the anti-pathogenicagent and sterilized. In some embodiments, the visual change reactantcan undergo a transition to indicate that the working-end site dried.Exemplary visual change reactants can include a number of dyes suitablefor this purpose known to those of skill in the art. In someembodiments, the visual change observed on either the surface of theworking end-site or the sterilizing element 20 itself, as describedabove, can be a visual color change.

In further embodiments, the sterilizing element 20 can be translucent oreven transparent such that a visual change in the working end-site oreven the sterilizing element 20 can be easily and readily observed bythe user through the sterilizing element 20 to the end-site. Forexample, in one embodiment a the translucent/transparent sterilizingelement 20 including a microtextured, micropatterned or microporoussurface, such as described above, provides the clinician with a view ofrefraction that occurs when the wetted, resilient surface of thesterilizing element 20 contacts the harder, more ridged surfaces of theend-site causing a visual change to occur from a darker appearance whencontact is first made to a lighter appearance following the removal ofthe sterilizing element 20 and the end-site allowed to dry

FIGS. 2A-2B are cross-sectional views of a sterilizing element 20,according to various embodiments of the present invention. According tosome embodiments, the contoured sterilizing element includes anabsorbent foam piece 22 having a recessed portion 24 including an innersurface 25 configured for receiving the working end-site of a medicaldevice to be sterilized therein. According to one embodiment, therecessed portion 25 is configured such that the working end-site can beinserted to a depth of approximately 10 mm. In other embodiments, therecessed portion 25 is configured such that the working end-site can beinserted into the recessed portion 25 by a depth of about 5 mm to about7 mm. In yet another embodiment, the working end-site may be insertedinto the recessed portion 25 by a depth of about 3 mm.

As shown in FIGS. 2A and 2B, the recessed portion 24 can include aplurality of raised structures 26 formed on the inner surface 25 of therecessed portion 24. The raised structures 26 project into the recessedportion, and are configured to engage the threads, sides, and/or edgeson the working end-site. In some embodiments, the raised structures 26can include ridges, flanges, and/or threads, as shown in FIG. 2A, stepsas shown in FIG. 2B, or combinations thereof. According to a furtherembodiment, as shown in FIG. 2B, the raised structures 26 provided onthe inner surface 25 of the recessed portion 24 provide an innerdiameter 31 that tapers down from a first end 33 to a second end 35 ofthe sterilizing element 20. These raised structures 26 located on theinner surface 25 of the recessed portion or cavity 24 of the sterilizingelement 20 facilitate the effective sterilization of all surfaces of theworking end-site of a first connection device prior to the attachmentwith a complimentary second connection device.

Additionally, in some embodiments the recessed portion 24 can include araised base portion 29 configured to project into and engage the innerluer lumen and/or septum of a needleless connector or port end. Theraised base portion can have a number of configurations. For example,the raised base portion 29 can be configured as any one of a nipple,bump, nub, tine, or other similar projection.

FIG. 2C is a cross-sectional view of a sterilizing element 20 accordingto yet another embodiment of the present invention. As shown in FIG. 2Cthe sterilizing element 20 includes a generally, cylindrical absorbentfoam piece 22 having a recessed portion 24. The cylindrical foam piece22 can be contoured and shaped so that it “form-fits” over the workingend-site of a luer compatible connector, medical device connectorcomponent, and/or needle access port for efficient wiping andsterilizing. In one embodiment, as shown in FIG. 2C, the recessedportion 24 has an inner diameter 31 less than an outer diameter of theworking end-site to be sterilized such that when a working end-site isreceived in the recessed portion 24 the inner walls 37 of the recessedportion conform to the outer surfaces of the working ends site. In someembodiments, the sterilizing element 20 may include a raised baseportion 29 configured to project into and engage the surfaces of aninner lumen or septum, as described above.

FIG. 3 is an isometric view of a sterilizing element 20 according toanother embodiment of the present invention. The sterilizing element 20is made from a foam or sponge-like material and is die cut to conform tothe surfaces of the working end-site to be sterilized. The die cutsterilizing element 20 can be cut in a number of configurations, suchthat it conforms to a variety of medical device connectors, components,and access ports. Additionally, according to some embodiments, the diecut sterilizing element 20 can be cut such that it is especiallyconfigured to accommodate a device having a lumen or septum. Forexample, the die cut sterilizing element 20 may be cut such that it isconfigured to project into and engage the inner surfaces of the amedical device having an inner lumen and/or a septum. In one embodiment,as shown in FIG. 3, the sterilizing element 20 includes an absorbentfoam piece 22 that is die-cut to include at least one slit 39 formedalong a longitudinal axis Y of the element 20 such that when a workingend-site is depressed into the sterilizing element 20, the slit 39 opensto receive the working end-site therein. The slit 39 includes side walls43 configured to conform to the surfaces of the working end-site to besterilized.

FIG. 4 is a cross-sectional view of a sterilizing element 20, accordingto yet another embodiment of the present invention, including a workingend-site 45 of a device to be sterilized received therein. As shown inFIG. 4, the sterilizing element 20 includes an absorbent, resilientarticle 47. In one embodiment, the absorbent resilient article 47 isfabricated from a viscoelastic foam (e.g. viscoelastic polyurethanefoam). The absorbent, resilient article 47 has sufficient resiliencysuch that when the working end-site 45 is pressed into the resilientarticle 47, the resilient article 47 depresses to receive the workingend-site 45 to a depth sufficient for the effective wiping andsterilization of the working end-site 45. Additionally, when the workingend-site 45 is pressed into the resilient article 47 to a sufficientdepth, the depressed resilient article 47 conforms to the outer surfacesof the working end-site 45.

The sterilizing element 20, according to the various embodiments,described above may be formed using a variety of techniques. Accordingto one embodiment, the sterilizing element 20 may be heat-set, molded,pressure-molded, injection-molded, cored, laser, and/or die cut. Othertechniques known to those of skill in the art for forming and shapingfoam may also be used.

FIGS. 5A and 5B are isometric views of a sterilizing device 50 accordingto various embodiments of the present invention. As shown in FIGS. 5Aand 5B, the sterilizing device 50 includes a sterilizing element 20,such as described above, according to the various embodiments, containedwithin a housing 60. According to some embodiments, the sterilizingelement 20 is contained within the housing 60 such that the housing 60provides a barrier to direct contact with the sterilizing element 20when the sterilizing element 20 is in use, and serves as a tool formechanically manipulating the sterilizing element 20. According tovarious embodiments, as will be described in further detail below, thehousing 60 can include a top or lid to seal and protect thepre-moistened sterilizing element from drying out within the housinguntil it is ready for use.

The sterilizing element 20 is secured within the housing 60 to preventdislodgement of the sterilizing element 20 from the working end-site ofthe device being sterilized. The sterilizing element 20 should besufficiently secured within the housing 60 such that it can withstandvigorous wiping of an end-site. The sterilizing element 20 can besecured within the housing by various methods including, but not limitedto, the following: ultrasonic welding, inward indentations of the walls,internal molded ribs or points, adhesives, frictional engagement, aswell as the sterilizing element's own outward expanding radial force tohold it in place within the housing.

According to other embodiments, the sterilizing element 20 may beremoved from the housing/packaging for attachment to and sterilizing ofthe end-site, as well as be directly held by and in the hand of the userto sterilize the end-site. The sterilizing element 20 has an inclusivelayer of anti-pathogenic which to sterilize both the working end-siteand the user's fingers. Alternatively, the contoured sterilizing element20 may be left in place within the housing and the whole device can beleft on the end-site for the purpose of protecting the site's sterilityuntil such time the device is removed so that the site end can be used.

According to various embodiments, the housing 60 is small andergonomically shaped so as to be easily held within the fingers of onehand of the user. In certain embodiments, the housing 60 is configuredto be opened single handedly using the fingers on one hand.Additionally, the housing 60 can have a general shape such as anhour-glass or flared shape that guides the placement of a user'sfingers. According to other embodiments, the housing 60 can include oneor more fingers locating features 65 formed with sidewalls 66 and 68 ofthe housing 60 to guide a user's placement of their fingers when usingthe device 50. The finger locating features 65 may also facilitategripping and handling of the device by the user. According to variousembodiments, the finger locating features 65 can include but are notlimited to be dimples, bumps, grip marks, and other features useful forlocating a user's fingers. As shown in FIGS. 5A and 5B the fingerlocating features 65 include recesses formed in the sidewalls 66 and 68of the housing 60. According to some embodiments, the housing 60 can beopened using the fingers on a single hand.

The housing 60 is sized to receive the working end-site of a medicalconnection inserted therein. The medical device or working end-site isinserted into the housing to access the sterilizing element 20 containedtherein. According to one embodiment, the housing 60 is configured suchthat the working end-site can be inserted to a depth of approximately 5mm. In other embodiments, the housing 60 is configured such that theworking end-site can be inserted into the housing 60 by a depth of about3 mm to about 5 mm. In yet another embodiment, the working end-site maybe inserted into the housing by a depth of about 4 mm.

The housing 60 can be made from a variety of materials. According tosome embodiments, the housing 60 is made from a plastic, laminatedpaper/foil combination, or other semi-rigid material or semi-flexiblematerial. As shown in FIG. 5A, a top portion 62 of the housing 60 can bepinched closed to form a seal 64. The seal 64 may be formed usingultrasonic welding, heat thinning and/or a liquid impermeable polyolefinfilm forming a combination molded seam and parting seal. As shown inFIG. 5B, the user squeezes the sidewalls 66 and 68 of the housing 60inward with the fingers of one hand such that the seal 64 formed alongthe top portion 62 opens to form opening 72. The opening 72 is sized toreceive the working end-site of a connection device or other medicaldevice therein. In some embodiments, the squeezing action causes anaudible “popping sound” as the seal 64 is forced open. Opening the seal64 exposes the sterilizing element 20 secured within the housing 60 andallows for receipt therein of the working end-site of the connectiondevice or other medical device to be sterilized.

FIG. 6 is an isometric view of a sterilizing device 100 including apre-moistened sterilizing element 20 contained within a housing 110according to another embodiment of the present invention. Thesterilizing element 20 can have any configuration according to thevarious embodiments, as described above. As shown in FIG. 6, the housing110 shows a frangible top 112 that can be sealed onto the housing 110utilizing a combined molded seam and parting seal 114. The top 112 issecured to the housing 110 such that when the user squeezes thesidewalls 116 of the housing 110 with the fingers of one hand, the sealalong the top 114 releases due to an increase in internal pneumaticpressure causing the top 112 to pop off and detach from the housing 110to create an opening 120 facilitating access to the sterilizing element20 contained inside.

FIGS. 7A and 7B are isometric views of a sterilizing device 130according to another embodiment of the present invention. Thesterilizing device 130 includes a pre-moistened sterilizing element 20contained within a housing 140 having an opening 142, sized to receivethe working end-site of a medical device. The sterilizing element 20 canhave any configuration according to the various embodiments, asdescribed above. The housing 140 includes a removable cover 144. Asshown in FIG. 7A, the removable cover 144 can be secured to the housing140 via a circumferential frangible tear line 148. As shown in FIG. 7B,the cover 144 can be removed using a twisting and pulling motion todetach the cover 144 from the housing 140 via the tear line 148. In someembodiments, the cover 144 and the body 140 can be made of plastic,mylar, foil, laminated foil, or other flexible material. In otherembodiments, the cover 144 can be made of a semi-flexible or semi-rigidmaterial.

FIGS. 8 and 9 are isometric views of a sterilizing device 150 includinga pre-moistened sterilizing element 20 contained within a housing 160having a removable cover 162 according to another embodiment of thepresent invention. The sterilizing element 20 can have any configurationaccording to the various embodiments, as described above. According toone embodiment, the removable cover 162 is a peel-away lid. As shownbest shown in FIG. 8, the cover 162 is secured over the top opening 164of the housing 160 such that it seals the pre-moistened sterilizingelement 20 within. The cover 162 includes a circumferential tear line166 for facilitating its removal. Additionally, the cover 162 can alsoinclude a tab or tether 168. According to one embodiment, as shown inFIG. 9, a user manually grasps the tab or tether 168 and pulls the cover162 from the housing via the tear line 166 to reveal the opening 164 andgrant access to the sterilizing element 20 contained within.

FIGS. 10 and 11 are isometric views of a sterilizing device 200including a pre-moistened sterilizing element 20 contained within aflexible envelope housing 210 according to yet another embodiment of thepresent invention. The sterilizing element 20 can have any configurationaccording to the various embodiments, as described above. The flexibleenvelope housing 210 may be formed from plastic, mylar, foil, laminated,or other flexible material. According to a further embodiment, theflexible envelope housing 210 may include a foil lining to furthermaintain the moisture level of the sterilizing element contained within.As shown in FIGS. 10 and 11, the flexible envelope housing 210 includesa removable protective cover 216. The removable protective cover 216 caninclude a line of perforations or weakness 218 configured to facilitateremoval of the protective cover 216 from the housing 210. The removableprotective cover 216 may be removed from the housing by tearing orcutting along the line 218. FIG. 11 shows the protective cover 216removed from the housing 210 to create an opening 220 facilitatingaccess to the sterilizing element 20 contained within.

FIG. 12 is an isometric view of sterilizing device 250 according toanother embodiment of the present invention. The sterilizing device 250includes a flexible envelope housing 260 including an inner lining 266and a removable protective cover 270. In some embodiments, the removableprotective cover 270 can be removed from the housing 260 by tearing orcutting along a perforation line or other similar line of weakness. Theprotective cover 270 is shown removed from the housing 260 in FIG. 12.

The inner lining 266 can be made of a particulate free absorbent foam orsponge-like material. The absorbent foam or sponge-like material ispre-moistened with an anti-pathogenic agent, as previously describedabove and lines the inner walls of the envelope housing 260. The innerfoam lining 266 is contoured and can include a plurality of raisedridges, ribs or threads configured to engage the threads, sides, and/oredges on the working end-site. Additionally, as shown in FIG. 12, theinner foam lining 266 includes raised base 268 configured to projectinto and to engage the inner luer lumen and/or septum of a needlelessconnector or port end. Additionally, according to a further embodiment,the inner lining 266 can include a reinforced oval rim 274. Thereinforced oval rim 274 is adapted to flex from a closed position to anopen position by squeezing the sides 278 of the flexible envelopehousing 260 upon removal of the protective cover 270. The rim 274 isflexed open to facilitate the reception of a working end-site of adevice to be sterilized within the inner lining 266 of the envelope 260.

FIG. 13A is an isometric view of a sterilizing device 300 including asterilizing element 20 contained within a generally cylindrical housing360. The sterilizing element 20 can have any configuration according tothe various embodiments, as described above. According to oneembodiment, the housing 360 includes a frangible lid 370. The lid 370seals the pre-moistened sterilizing element 20 and maintains a moisturerich environment inside the housing 360. According to variousembodiments, the frangible lid 370 can be made of plastic, mylar, foil,laminated foil, laminate, or other similar material. In someembodiments, the frangible lid may include score-marks 372 to facilitatebreaking of the frangible lid 370. The frangible lid 370 should be ofsufficient thickness and frangibility, that the working end-site 375 (asshown in FIG. 13B) of a device to be sterilized, can penetrate the lidby forcibly engaging the working end-site through the pre-scored lid toaccess the sterilizing element 20 contained within the housing 360. FIG.13B shows a working end-site of a device to be sterilized forciblyengaged through the frangible top 370 of the sterilizing device 300.

In some embodiments, the housing 360 is sized to facilitate prolapse ofthe frangible lid 370 into the housing 360. For example, as the workingend-site 375 is being forcibly engaged through the frangible lid 370,the lid material pushes inward and down into the housing 360 such thatthe working end-site 375 can access and engage the sterilizing element20 contained within the housing 360. In some embodiments, the workingend-site 375 can be left engaged with the sterilizing element 20contained within the housing 360 until the end-site 375 is ready foruse. Together with the lid 370, the housing 360 and the sterilizingelement 20 have sufficient integrity and durability such that the device300 resists removal of the end-site 375 from the device 300 thusallowing the device 300 to be left engaged with the end-site 375 withoutthe potential for inadvertent disengagement from the device 300.According to one embodiment, the housing 360 provides a depth of lessthan about 10 mm to facilitate prolapse of the lid 370 into the housing360. In another embodiment, the housing 360 provides a depth of about 5mm to about 10 mm, of about 3 to about 5 mm, and/or about 4 mm tofacilitate prolapse of the lid 370 into the housing 360.

FIG. 14 shows a sterilizing device 460 according to a further embodimentof the present invention. As shown in FIG. 14, the sterilizing device460 includes a pre-moistened sterilizing element 20 according to thevarious embodiments as described above, contained within a housing 470having a lid 474 and an additional debris protective covering 480. Thelid 474 is secured to the top of the housing 470 to seal thepre-moistened sterilizing element 20 within the housing. According toone embodiment, as previously described above, the lid 474 is a foil orplastic frangible lid and may be pre-scored to include score-marks.Additionally, the lid 474 is of sufficient thickness and frangibilitysuch that a working end-site of a device to be sterilized can be forcedthrough the lid 474 to access the sterilizing element 20 containedwithin the housing 470.

The debris protective covering 480 is positioned adjacent and secured tothe lid 474. The debris protective covering assists in keeping thedevice lid 474 free of debris until the device is ready for use. Thedebris protective covering 480 extends outward beyond an outer diameterof the housing 470. This configuration helps to stabilize the device 460and may prevent it from rolling when the device 460 is placed on itsside. Additionally, the configuration may provide a wider, sturdier basefor the device 460, if the device is placed top-side-down on a flatsurface. The debris protective covering 480, as shown in FIG. 14, can beused in conjunction within a variety of housing configurations, such asthose described above.

FIG. 15 is an isometric view of a dual sided sterilizing device 500according to yet another embodiment of the present invention. As shownin FIG. 15 the dual sided sterilizing device 500 includes an elongatedergonomic housing 510, having a first end 512 including a first opening514 and a second end 516 including a second opening 518. At least onesterilizing element 520 is located within the housing 510 and can beaccessed through either the first or second opening 514 or 518.

According to one embodiment, the housing 510 includes a seal or lid 530located over each of the first and second openings 514 and 518. The lidor seal 530 can have any one of the configurations as described above.According to one embodiment, as shown in FIG. 15, the lid 530 can be apre-scored lid. According to further embodiments each of the first andsecond ends 512 and 516 can include a plastic, foil, or laminated lid530 that is of sufficient thickness and frangibility that a workingend-site of a device to be sterilized can be forced through the lid togain access to the sterilizing element contained inside. In someembodiments, a protective covering, such as described above withreference to FIG. 14, may be secured to the lid 530.

According to various embodiments, the dual sterilizing element 520contained within the housing 510 can be made from a non-woven,particulate free absorbent foam, or sponge-like material. The absorbentfoam or sponge-like material is pre-moistened with an anti-pathogenicagent including any one of an antiseptic, disinfectant, microbiocidal,or combinations thereof to kill pathogens on the surfaces of the device.Additionally, the sterilizing element 520 is contoured and shaped sothat it “form-fits” over the working end-site of a luer compatibleconnector, device, and/or needle access port for efficient wiping andsterilizing. According to one embodiment, the sterilizing element 520can extend continuously from the first end 512 to the second end 516throughout the entire housing length 510. According to anotherembodiment, described in further detail below, the sterilizing element520 can include two separate portions contained within the housing 510.

Like the housing 510, the dual sterilizing element 500 includes a firstend 522 and a second end 524. Each end 522 and 524 can be shaped to fitto the various male, female (inner lumen), slip luer, septum, port, orthreaded configurations of a working end-site to be sterilized, andapply an inclusive layer of an anti-pathogenic agent to sterilize andwipe debris from the site while using a wiping and twisting motion.According to one embodiment, each end 522 and 524 can have the samecontouring. According to another embodiment, the first end 522 and thesecond end 524 can have different contouring. For example, the first end522 can be contoured such that it contacts and engages the surfaces of amale connection component (e.g. male luer lock or a slip luer) and thesecond end 524 can be contoured such that it projects into and engagesthe surfaces of various female (inner lumens) and/or septums (e.g. aneedleless injection port).

According to further embodiments, each of the first and second ends 514and 518 can include a label (not shown) located on an outer surface ofthe housing 510. The label can be embossed or printed withdifferentiating numbers, letters, or symbols to assist the clinician inidentifying which end of the housing they are using. Using labels toidentify the working ends 514 and 518 is useful, for example, when thefirst and second ends 522 and 524 of the sterilizing element 520 differso as to be used to clean and sterilize different medical devices.Additionally, labels to identify the working ends 514 and 518 of thedevice 500 are also useful when the anti-pathogenic agents on the firstand second ends 522 and 524 of the sterilizing element 520 differ suchthat the anti-pathogenic agent can be selected depending on the materialto be sterilized. In certain embodiments, when the sterilizing device500 is left engaged with the working end-site after it has been cleanedand sterilized, a label can be used to signify to the user or users thatthe connection has been sterilized and is ready for use.

FIG. 16 is a schematic view of the dual sided sterilizing device 500shown in FIG. 15 according to another embodiment of the presentinvention. According to one embodiment, as shown in FIG. 16, a divideror partition 560 separates the device into two distinct portions 562 and564. According to this embodiment, each of the portions 562 and 564contain a separate sterilizing element 520 a or 520 b. The sterilizingelements 520 a and 520 b are secured to the divider in a back-to-backarrangement. The sterilizing elements 520 a and 520 b can have the sameor different contour configurations. For example sterilizing element 520a can be configured to engage male luer connections and sterilizingelement 520 b can be configured to engage female luer connections and/orseptums. Additionally, the sterilizing elements 520 a and 520 b can bepre-moistened with the same or different anti-pathogenic agent.According to yet another embodiment, the second sterilizing element 520b can be dry and can be used to dry the working end-site after theworking end-site has been cleaned and sterilized using the firstpre-moistened sterilizing element 520 a. The second portion 564containing the dry sterilizing element can be left engaged with theworking end-site until the end-site is ready for use.

FIGS. 17 and 18 show a combined sterilizing device 600 according to yetanother embodiment of the present invention. As shown in FIGS. 17 and18, the sterilizing device 600 includes a housing 610 and a cover 616.Each of the housing 610 and the cover 616 contain a sterilizing element620 a and 620 b, respectively. The sterilizing elements 620 a and 620 bcan have any one of the configurations according to the variousembodiments described above. The cover 616 is coupled to the housing 610via a frangible seal 630, as shown in FIG. 17. The cover 616 can beseparated from the housing 610 by a twisting and pulling motion to gainaccess to the sterilizing elements 620 a and 620 b through separateopenings 624 a and 624 b located in the housing 610 and the cover 616,respectively. The housing and cover portions 610 and 616 of the device600 can be used separately to clean and sterilize the working end-sitesof one or more devices to be sterilized. According to furtherembodiments, the sterilizing elements 620 a and 620 b contained withinthe housing 610 and cover 616, respectively, can have the same ordifferent configurations. Additionally, the sterilizing elements 620 aand 620 b can be pre-moistened with the same or differentanti-pathogenic agent. For example, the sterilizing element 620 alocated within the housing 610 can be contoured so as to contact andengage the surfaces of male devices and can be pre-moistened with afirst anti-pathogenic agent, and the sterilizing element 620 b locatedwithin the cover 616 can be contoured so as to contact and engage theinner surfaces and a device having a lumen and/or septum and can bepre-moistened with the same or a second anti-pathogenic agent. Accordingto other embodiments, the first sterilizing element 620 a can bepre-moistened with an anti-pathogenic agent and is used to clean andsterilize the working end-site. The second sterilizing element 620 b canbe dry and used to dry the working end-site after it has been cleanedusing the first sterilizing element 620 a. The cover 616 including thedry sterilizing element 620 b may be left engaged with the workingend-site until the site is ready for use.

FIGS. 19A and B are partial cut-away views of a sterilizing device 650according to still other embodiments of the present invention. As shownin both FIGS. 19A and 19B, the sterilizing device 650 includes anelongated housing 660 having an upper portion 664 and a lower portion668. A pre-moistened sterilizing element 670, according to any one ofthe various embodiments as described above, is sealed within the upperportion 664 of the housing 660 by a frangible top 674. According to oneembodiment, a protective cover 676, such as previously described above,can be provided over the frangible top 674. In one embodiment, as shownin FIG. 19A, the lower portion 668 of housing 660 includes a divider orpartition 680 and a female luer 684 attached to an underside 686 of thedivider 680. The female luer 684 is configured such that it can besecured onto a working end 688, for example, of a male luer lock syringe690 or slip luer style syringe. The lower portion 668 of the housing 660covers the syringe end 688 when the female luer 684 is coupled to thesyringe end 688.

According to another embodiment, as shown in FIG. 19B, the lower portion668 of the housing provides an inner surface to be retained onto theoutside surface of the syringe 688. The lower portion 668 includes aninner lining 691 that has “grippable” or a textured surface that wouldallow the clinician to rotate the attached sterilizing device 650 eitherclockwise or counter clockwise in a manner to sterilize the end-site ofthe medical device while attached to the syringe end 668. The innerlining 691, along with a textured partition 680, provides ahigh-friction contact surface to prevent slippage of the housing 660 andparticularly the lower portion 668 of the device 650 coupled to thesyringe end 688. The grippable inner lining 691 having a texturedsurface provides an additional method of securing the sterilizing device650 to the outer-housing of the syringe 690, particularly when the useris swabbing an end-site in a counter-clockwise direction where apartition 680 containing a female luer is coupled to the male luer lockon a syringe-end 688, such as shown in FIG. 19A, as it is generallyrecognized that a female luer coupled to a male luer lock aremechanically suitable for a clockwise rotation, but not a counterclockwise, rotation. Additionally, the lining 691 provides theadditional high-friction for the user to turn the syringe 690 in acounter-clockwise direction to minimize the risk of the syringe 690 andsterilizing device 650 separating during a vigorous bi-directional(clockwise or counter clockwise) cleaning of the end-site. Further, inanother embodiment, the lower portion 668 of the sterilizing device 650does not include a female luer, and the inner lining 691, in conjunctionwith having a textured/lined partition 680, provides the necessary gripalone to the syringe's outer-housing/shroud (i.e. male luer locksyringe) for a bi-directional cleaning.

Additionally, in other embodiments, as shown in FIG. 19B the lowerportion 668 can also include a sterilizing element 695 configured suchthat the inner cavity 624 of the sterilizing element 695 as well as theexterior 684 of the sterilizing element 695 would provide an alternativemethod for gripping the inner surface 696 of the male luer lock syringeend 688 and/or in conjunction with the inner lining 691 and/or the outersurface 697 of the slip luer portion 698 of the syringe 690. Together orin part, the lower portion 668 inner lining 691 and/or the sterilizingelement 695 would provide a friction fit such that the clinician canrotate in either a clockwise or counter clockwise direction tosterilizing the medical device end-site. with the sterilizing element695. Thus, the device 650, as described above according to the variousembodiments, serves as both a sterilizing device and as an end-cap tokeep the syringe end sterile and free from debris until the syringe isready for use. After the working end-site of the medical connector hasbeen wiped free of debris and is sterilized using the device 650, thehousing 660 and lower portion 668, including the female luer 684 and/orsterilizing element 695, can be disengaged from the male end 688 of thesyringe 690, and the contents of the syringe 690 can then be injectedinto the working end-site of the sterilized medical connector.

FIG. 20 shows a sterilizing device 700 according to the variousembodiments of the present invention, as described above, used tosterilize the working end-site 705 of a medical device 710. Thesterilizing device 700 is intended for a single application and shouldbe disposed of in the appropriate waste receptacle. The sterilizingdevice 700 includes a contoured sterilizing element 720 pre-moistenedwith an anti-pathogenic agent contained within a housing 740. In orderto use the sterilizing device 700, the protective cover (if present) isfirst removed. Next, the housing 740 is opened to facilitate access tothe sterilizing element. According to some embodiments, the housing 740can be opened by peeling away or removing a lid secured to the top ofhousing. In other embodiments, the housing 740 may be opened by theapplication of inward pressure on the housing side walls to either breaka seal formed at the top of the housing 740 or to pop off a lid. Instill other embodiments, a working end-site of a device to be sterilizedcan be forcibly engaged through a frangible pre-scored lid orfoil/laminated top to gain access to the sterilizing element 720contained within the housing 740.

Once the housing 740 has been opened, the working end-site 705 of thedevice to be sterilized 710 is then inserted through the opening 745 ofthe sterilizing device housing 740 to access the sterilizing element 720contained within, as shown in FIG. 20. The end-site 705 is inserted intothe recessed portion 748 of the sterilizing element 720, such that thesterilizing element 720 contours to the outer threads, edges, sides, andinner lumen surfaces of the medical connector end. As shown in FIG. 20,the sterilizing element 720 includes a recessed portion 748 configuredto contour to the outer surfaces and threads of the end-site and araised base portion 750 adapted to contact and engage the distal endincluding the distal tip of the working end-site 705 as well as theinner lumen of the medical connector, as described above.

Debris is cleared from and an inclusive layer of ant-pathogenic agent isapplied to the end surfaces of the working end-site 705 with thecontoured sterilizing element 720 using a wiping and/or twisting motionfor sufficient amount of time so as to achieve a specific “kill ofmicrobes.” According to some embodiments, cleaning and sterilizing theworking end-site 705 includes expelling the anti-pathogenic agent ontothe working end-site 705. For example, in one embodiment, the workingend-site 705 is compressed into the sterilizing element 720 to expel theanti-pathogenic agent from the element 720 and onto the working end-site705. In another exemplary embodiment, the anti-pathogenic agent can beexpelled onto the working end-site 705 by squeezing the sidewalls of thehousing 740 to compress the sterilizing element 720 contained therein toexpel the anti-pathogenic agent onto the working end-site 705. Accordingto one embodiment, the cleaning time is less than about 30 seconds.According to another embodiment, the cleaning time ranges from about 20to about 30 seconds; from about 15 to about 30 seconds; or from about 10to about 30 seconds. In some embodiments, the sterilizing device 740 maybe left engaged with the working end-site 710 until ready for use.

Once the working end-site 705 has been cleaned and sterilized for theappropriate amount of time, the working end-site then can be removedfrom the sterilizing element 720 and the housing 740, and allowed to airdry prior to connection of another compatible device or an injectionmade therein with a syringe. According to one embodiment, the dryingrate after the anti-pathogenic agent has been applied to the workingend-site is less than about 15 seconds. In other embodiments, the dryingrate is less than about 10 seconds. In still other embodiments, thedrying rate is less than about 7 seconds.

In other embodiments, a second end of the sterilizing device or anadditional device including a dry element may be used to wipe dry theworking end-site 705 after it has been cleaned and sterilized asdescribed above. The second end or additional drying device may be leftin place engaged within the working end-site until ready for use.

FIG. 21A is a partial cut-away view of a sterilizing device 800 providedin accordance with various embodiments of the present invention and anexemplary connector end 804. As shown in FIG. 21A, the exemplaryconnector end 804 is a male luer lock connector including a male slipluer component 808 and a shroud 810 that covers and protects the slipluer component 808. An internal cavity 812 is defined between the shroud810 and the slip luer component 808. The internal cavity 812 may includea plurality of internal threads provided on an inner wall or surface 813of the shroud 810. The male slip luer component 808 includes a lumen 814having an inner surface 816 and completes the fluid pathway common tomale luer lock connectors.

According to various embodiments, the sterilizing device 800 includes asterilizing element 820 contained within a housing 830. The sterilizingelement 820 can have any one of the configurations according to thevarious embodiments described above. In one exemplary embodiment, thesterilizing element 820 includes an absorbent material pre-moistenedwith an anti-pathogenic agent. In certain embodiments, as shown in FIG.21A. The housing 830 defines a cavity 831 between an outer surface 833of the sterilizing element 820 and an inner wall 835 of the housing 830to receive and couple with the male luer lock shroud 810. Additionally,the sterilizing element 820 includes a recessed portion 832 configuredto receive and conform to the male slip luer component 808 (if present).Additionally, the sterilizing element 820 includes a raised base portion834 configured to project into and engage an inner surface 816 of theslip luer lumen 814. Further, in certain embodiments, the outer surface833 of the sterilizing element can be contoured to include, but notlimited, ribs, threads, flanges or raised structures 838 and to contactall inner walls of the shroud 810 and to facilitate the wiping andsterilizing therein. The housing 830 can have a number ofconfigurations, according to the various embodiments described above.

FIG. 21B is a partial cut-away view of the sterilizing device 800coupled with the male luer lock connector 804. In certain embodiments,as shown in FIG. 21B, the housing 830 is sized to fit over the shroud810. The male slip luer component 808 (if present) is received andengaged in the recessed portion 832 of the sterilizing element. Thesterilizing element 820, as shown in FIG. 21B, fills the internal cavity812 defined by the shroud 810. Additionally, the shroud 810 fitssufficiently in housing cavity 831 between inner housing wall 835 andthe outer wall 833 of the sterilizing element 820. The raised baseportion 834 projects into and engages the inner surface 816 of the slipluer lumen 814. In some embodiments, the outer wall 833 of thesterilizing element 820 may include external surface features 838configured to engage and contact any internal threads provided on theinternal surfaces 813 of the shroud 810. Once the male luer connector804 is engaged within the sterilizing element 820 contained within thehousing 830, a wiping and/or twisting motion can be employed to wipedebris from and apply an inclusive layer of the anti-pathogenic agent tothe inner and outer surfaces 812 of the male luer connector 804including the inner surface 816 of the lumen 814. Once the male luerconnector 804 has been effectively cleaned and sterilized, thesterilizing device 800 can be left on the end-site to protect itssterility until time of use and then disposed of in the appropriatewaste receptacle. In certain embodiments, such as in the absence of amale connection component, the sterilizing element can be inserted intothe cavity 831 defined by the shroud 810. Once the sterilizing elementis engaged in the shroud, a wiping and/or twisting motion can beemployed to clean and sterilize the surfaces of the medical device to becleaned. The sterilizing device 820 can be left engaged in the shroud810 until the device is ready for use.

FIGS. 22A and 22B are isometric views of a contoured sterilizing tool900 according to still another embodiment of the present invention. Asshown in FIGS. 22A and 22B, the contoured sterilizing tool 900 includesa contoured sterilizing element 904 transposed into and onto a singleplanar sheet 908 of a resilient material. The contoured sterilizingelement 904 is transposed into the sheet 908 such that either or bothsides of the contoured sterilizing tool 900 can be utilized for wipingand sterilizing a working end-site 912, 912′ of a medical device 914,914′. The contoured sterilizing tool 900 can be left on the medicaldevice end-site 912, 912′ to keep it sterile and clean until access isrequired.

The contoured sterilizing element 904 is transposed in the resilient,planar sheet 908 such that it defines a cavity 920 in an upper planarsurface 922 of the planar sheet 908. The cavity 920 includes an innersurface 924 configured to receive a working end-site of a medical devicetherein such as, for example, the female-type working end-site 912 of amedical device 914 as shown in FIG. 22A. The inner surface 924 isconfigured to conform and contour to and to contact the outer and innersurfaces of the working end-end site 912 and, in some embodiments, caninclude any number of raised structures including ribs, threads, ridges,micropatterned features, microtextured features and the like configuredto conform and to contact the surfaces to be sterilized. In someembodiments, the cavity 920 includes a base surface 926 including araised base portion 928 configured to contact and to engage an innersurface of the working end-site of a medical device such as, forexample, a lumen, a distal end and/or a septum. To accomplish this, theraised base portion 928 can have any number of configurations. Forexample, the raised base portion 928 can be configured as any one of anipple, bump, nub, tine, or other similar projection.

The contoured sterilizing element 904 is transposed in the resilient,planar sheet 908 such that in addition to defining the cavity 920, thecontoured sterilizing element 904 also defines an outwardly projectingportion 930. The outwardly projecting portion 930 projects away from thelower planar surface 932 of the resilient planar sheet 908. In someembodiments, the outwardly projecting portion 930 has an outer shapethat complements the inner shape of the cavity 920. The outwardlyprojecting portion 930 includes an outer surface 934 shaped to conformand contour to and to contact the outer and inner surfaces of a medicaldevice end-site such as, for example, the male-type working end-site912′ of a medical device 914′ as shown in FIG. 22B. Additionally, theouter surface 934 of the outwardly projecting portion 930 can includeany number of raised structures including ribs, threads, ridges,microtextured features, micropatterned features and the like configuredto contact and conform to the surfaces to be sterilized. In someembodiments, the outwardly projecting portion 930 includes a recessedportion 938 shaped to receive the outer and inner surfaces of a workingend-site of a medical device therein. In one embodiment, the recessedportion 938 has an exterior shape 942 that is transposed to complementan interior shape 944 of the raised base portion 928 formed as part ofthe cavity 920.

FIG. 23 is an isometric view of a contoured sterilizing tool 900according to further embodiments of the present invention. As shown inFIG. 23, the contoured sterilizing tool 900 can include a finger grip952 formed on the outer surface 934 of the outwardly projecting portion930. Additionally, the contoured sterilizing tool 900 can include aplurality of surface texturing features 954 formed on the upper planarsurface 922 and/or lower planar surface 932 of the resilient planarsheet 908. The surface texturing features 954 can have any configurationdesigned to facilitate gripping of the tool 900 including, but notlimited to, ridges, bumps, surface roughing, rings, concentric circles,lattice features and the like. The finger grip 952 and/or surfacetexturing features 954 are provided to facilitate gripping andmanipulation of the tool 900 by the user.

FIG. 24 is a schematic view of a contoured sterilizing tool 900, such asdescribed above in reference to FIGS. 22A-23, contained within apackaging 960. The packaging 960 is adapted to maintain a sterile and/ormoisture-rich environment within the packaging 960 when the packing issealed. In some embodiments, the packaging 960 is an easy-tear packagingthat can be easily torn open by the user to access the sterilizing tool900 contained within. In one embodiment, as shown, the contouredsterilizing tool 900 is adapted to be compressed to substantiallyflatten the transposed configuration within the packaging 960. When thepackaging 960 is opened and the sterilizing tool 900 removed, theresiliency of the material used to fabricate the tool 900 facilitatesthe outward projecting portion 930 of the sterilizing tool 900 tore-expand to an uncompressed configuration ready for use as shown, forexample, in either FIG. 22A or FIG. 22B.

According to various embodiments, the contoured sterilizing tool 900 canbe fabricated from a resilient, planar sheet of material 908. Theresilient planar sheet of material 908 can be selected from a widevariety of resilient materials of varying durometers and elasticity.Exemplary resilient materials include, but are not limited to silicones,rubbers including latex-free rubbers, viscoelastic foams, ethylenepropylene diene monomer rubbers (EPDM) and other suitable materialsknown to those of skill in the art. In some embodiments, the contouredsterilizing tool 900 can be made of a translucent, transparent oroptically clear resilient elastomeric material such as a silicone or alatex-free rubber. A translucent or optically clear sterilizing tool 900assists the user in visualizing and to see-through a change in theappearance of either the working end-site and/or the sterilizing toolitself during the cleaning and sterilization of the working end-site.

The contoured sterilizing tool 900 including the contoured sterilizingelement 904, as described above according to the various embodiments,can be transposed in the resilient, planar sheet 908 using a variety ofmanufacturing techniques. Exemplary techniques suitable for fabricatingthe sterilizing tool 900 include various molding methods such astransfer, compression or injection molding or other similar techniques.According to one embodiment, the contoured sterilizing element 904 canbe pressed or molded into the resilient, planar sheet 908.

In several embodiments, the resilient material used to form theresilient, planar sheet 908 is impregnated with a liquid or dryanti-pathogenic agent, such as described in detail above, for applyingan inclusive layer of an anti-pathogenic agent to the inner and outersurfaces of the working end-site of a medical device for sterilization.In some embodiments, the resilient planar sheet 908 can also beimpregnated with a visual-change reactant. The visual-change reactantmay cause the contoured sterilizing tool 900 and/or the working end-siteto undergo a visual change indicating that the working end-site of themedical device has been adequately sterilized and is ready for use. Forexample, in one embodiment, the sterilizing tool 900 can be impregnatedwith a visual change reactant that when applied to the surface of theworking end-site, causes the working end-site to change color. In afurther embodiment, the visual change reactant undergoes an additionalcolor change when the working-end site is dried. Exemplary agentssuitable for this purpose include dyes, reactants, catalysts and othersimilar agents suitable for this purpose known to those of skill in theart.

In some embodiments, the contoured sterilizing tool 900 is made from atranslucent or transparent material and provides a visual “see through”indication that the working end-site has received exposure from theanti-pathogenic agent contained within the contoured sterilizing tool900, causing a visual discoloration of the working end-site andindicating that the working end-site has been sterilized and is readyfor use. In some embodiments, the contoured sterilizing tool 900impregnated with an anti-pathogenic agent releases the anti-pathogenicagent upon contact with the working end-site of the medical device,wetting the surface with the anti-pathogenic agent causing a visualchange in the end-site due to a microporous (e.g., polymeric porouspermeable polymer), micropatterned, bonded coating or solvatochromicdyed surface (e.g., merocyanine dye or Reichardt's dye) of the end-site.In another embodiment the translucent/transparent contoured sterilizingtool 900 itself can include a micropatterned (e.g., fine lines orcracks), microtextured or a microporous surface whereby refractionoccurs when the wetted, “resilient” surface of the contoured sterilizingtool 900 contacts the “harder,” more ridged surfaces of the end-site,causing a visual change to occur from a darker appearance when contactis first made (i.e. wetted) to a lighter appearance as when thesterilizing tool 900 is left in place on the working end-site and theanti-pathogenic agent dries and/or evaporates. In further embodiments,the sterilizing tool 900 visually changes from a first state to a secondstate or similarly from visually light to visually dark or from a darkto a light surface over time due to exposure to an anti-pathogenicagent, and from a wetted surface to a dry surface. In other embodiments,the sterilizing tool 900 undergoes a visual change in response to manualpressure applied to the tool 900. According to the various embodimentsdescribed above, the visual change can be a color change. In otherembodiments, the micropattern or microtexturing provides an additionalrefinement to the contour sterilizing tool for contacting and cleaningintricate details on an end-site such as cracks, crevices or grooves andwhere microscopic bacterium can reside on an end-site and particularlywhere an end-site has been assemble with multiple components havingmicroscopic surfaces that can harbor bacterium (e.g. needle-lessconnector having assembled components such as a housing, seals, valve orseptum). The microtexturing or micropattern can be anyone of ridges,bumps, surface roughing, rings, concentric circles, lattice features andthe like. In a further embodiment of the contour sterilizing element 900can include a microporous surface adapted to retain a measured amount ofan antipathogenic agent such that the sterilizing element 900 is adaptedto apply an inclusive layer to an end-site in a manner to promote a fastdrying rate. In yet another embodiment, the microporous surface isadapted to deliver a pre-determined amount of anti-pathogenic agent forthe purpose of leaving a measured amount of anti-pathogenic residue tomaintain the sterility on the end-site.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

1. A contoured sterilizing tool for wiping, sterilizing and conformingto surfaces of a working end-site of a medical device, the contouredsterilizing tool comprising: a resilient sheet of material including aplanar surface; and a contoured sterilizing element transposed in theresilient sheet such that it projects away from the planar surface, thesterilizing element defining a cavity comprising an inner surfaceconfigured to conform and contour to and contact and to engage an outersurface of the working end-site of the medical device and a raised baseportion configured to conform and contour to and contact and to engagean inner surface of the working end-site of the medical device.
 2. Thecontoured sterilizing tool according to claim 1, wherein the sterilizingelement further defines an outwardly projecting portion having an outersurface shaped to conform and to contour to and to contact the outer andinner surfaces of the working end-site of the medical device.
 3. Thecontoured sterilizing tool according to claim 2, wherein the outersurface of the outwardly projecting portion includes one or more raisedstructures configured to conform and to contact the surfaces of theworking end-site of the medical device.
 4. The contoured sterilizingtool according to claim 1, wherein the outwardly projecting portioncomprises a recessed portion having an outer shape complementary to aninner shape of the raised base portion of the cavity.
 5. The contouredsterilizing tool according to claim 1, wherein the outwardly projectingportion is adapted to expand from a compressed configuration to anun-compressed configuration.
 6. The contoured sterilizing tool accordingto claim 1, wherein the inner surface of the cavity further comprisesone or more raised surface features configured to conform to and contactthe surfaces of the working end-site of the medical device.
 7. Thecontoured sterilizing tool according to claim 1, wherein the resilientsheet of material is impregnated with an anti-pathogenic agent.
 8. Thecontoured sterilizing tool according to claim 1, wherein the planarsurface of the resilient sheet includes a plurality of surface texturingfeatures.
 9. The contoured sterilizing tool according to claim 2,wherein the outwardly projecting portion comprises a finger grip. 10.The contoured sterilizing tool according to claim 1, wherein theresilient sheet comprises a visual change reactant that when applied tothe working end-site, visually indicates that the end-site has beencontacted with the sterilizing tool.
 11. The contoured sterilizing toolaccording to claim 1, wherein the contoured sterilizing tool furthercomprises an anti-pathogenic agent and is adapted to produce a visualchange on a working end-site including a surface treatment adapted toproduce a visual change when contacted with the anti-pathogenic agent.12. The contoured sterilizing tool according to claim 1, wherein theresilient sheet comprises a visual change reactant that is adapted toreact with a surface coating or treatment on a working end-site toproduce a visual change on the working end-site.
 13. The contouredsterilizing tool according to claim 1, wherein the resilient sheet isvisually translucent, transparent or optically clear.
 14. The contouredsterilizing tool according to claim 1, wherein the sterilizing tool isadapted to undergo a visual change.
 15. The contoured sterilizing toolaccording to claim 1, wherein the sterilizing tool is adapted to undergoa visual change in response to manual pressure applied to thesterilizing tool.
 16. The contoured sterilizing tool according to claim7, wherein the sterilizing tool leaves a residual anti-pathogenic agenton the end-site when removed from the end-site.
 17. The contouredsterilizing tool according to claim 1, wherein the tool is sized andshaped to be held in a single hand by the user.
 18. The contouredsterilizing tool according to claim 1, wherein the resilient sheetcomprises a silicone or latex free rubber.
 19. The contoured sterilizingtool according to claim 1, wherein the sterilizing tool furthercomprises a microporous, microtextured or micropattern, surface adaptedto undergo a visual change.
 20. The contoured sterilizing tool accordingto claim 1, wherein the sterilizing tool further comprises amicroporous, microtextured or micropatterned surface for detailedsterilizing of the working end-site.
 21. The contoured sterilizing toolaccording to claim 1, further comprising a packaging wherein thecontoured sterilizing tool is contained within the packaging and can beremoved therefrom.